FDA NMIBC Clinical Trial Design Workshop in NovemberIt's too late to effect Theralase's trial design but there may still a lot that is of interest to Theralase shareholders in this workshop, such as a discussion of the
BCG shortage and the presentation of patient perspectives. Moderators include two members of
Theralase's Medical and Scientific Advisory Board -
Dr. Michael O'Donnell and
Dr. Ashish Kamat and also
Dr. Peter Black, the Principal Investigator of Theralase's
UBC Clinical Study Site in Vancouver and
Dr. Neal Shore, the Principal Investigator of Theralase's
Carolina Urologic Research Cente Clinical Study Site in South Carolina.
Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC) Date: November 18 - 19, 2021
Day1: Thu, Nov 18 9:00 AM - 1:00 PM ET
Day2: Fri, Nov 19 9:00 AM - 12:00 PM ET
Organized By: Oncology Center of Excellence and the Center for Drug Evaluation and Research/Office of Oncologic Diseases
Twitter:# FDANMIBC21
Background
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and Center for Drug Evaluation and Research (CDER) welcome you to this FDA Virtual Public Workshop: Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC).
The purpose of this workshop is to discuss challenges and opportunities in clinical trial design for patients with NMIBC. The ultimate goal of the workshop is to identify actionable next steps towards facilitating feasible trial designs that can capture interpretable and clinically meaningful results.
Sessions 1-3 are on the first day of the workshop (Thursday, November 18th).
- The first two sessions will cover the BCG shortage, impact on clinical practice, and implications for trial design for the BCG-nave population.
- The third session will focus on trial design in the BCG-unresponsive population and potential trial designs with cystectomy-free survival as a secondary endpoint.
Sessions 4-6 will be on the second day of the workshop (Friday, November 19th).
- Sessions 4 and 5 will cover issues related to trial design for the two distinct classifications of NMIBC; i.e., carcinoma in situ and papillary disease.
- Session 6 will focus on capturing the patients’ perspective in trial design including experiences, needs, and priorities.
Workshop moderators and panelists include regulators, urologists, medical oncologists, and patients. We look forward to productive discussions during this workshop.
Meeting Goals
- Provide a forum for open discussion between academia, international regulators, and patient advocacy groups to advance clinical trial design in NMIBC;
- Develop greater precision around NMIBC disease states to facilitate the rational design of and appropriate patient selection for clinical trials in NMIBC;
- Identify questions that would benefit from further study; and
- Envision novel designs and endpoints for future trials.
Registration
This meeting will be held in virtual format only. Registration is required for online attendance and will be available until noon onNovember 19th, 2021.
Online Attendance
This meeting will be available for online viewing, on the day of the meeting via the following link:[url=https://fda.zoomgov.com/j/1602905396?][/url]
pwd=YTdjejEzY0hhZUNwenJWak9Jd0M2QT09External Link Disclaimer Passcode: 7Ec#Aj
Agenda Background Reading 2014 2018 Recordings for the workshop (available 2-3 weeks after the event)
Event Point of Contact
Joan Ferlo Todd, RN, MS
Senior Regulatory Health Project Manager
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC) U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Tel: 301.796.6079
Joan.Todd@fda.hhs.gov
Caitlin Drew, MSN, RN
Senior Regulatory Health Project Manager
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Tel: 301.318.8609
Caitlin.Drew@fda.hhs.gov